Dir. Commercial Regulatory Affairs & Quality Assurance, Leica Biosystems
Caroline Byrd has worked in the medical device industry for over 18 years holding various leadership positions in Regulatory, Quality, R&D, and Operations for small private companies and large corporations. She is currently a Director of Regulatory Affairs, based in Minnesota, focused on strategic EU Medical Device Regulation (MDR) implementation. Since 2016, Caroline has worked cross-functionally to scope the impacts of the MDR to Abbott Medical Device Division’s portfolio, quality and IT systems, and supply chain. Prior to her full time focus on the EU MDR, Caroline led the Clinical Evaluation, Preclinical, and Biocompatibility organizations for St. Jude Medical. Caroline is also a champion for product lifecycle management concepts and data management solutions that enable value-add compliance to regulation. She holds a BS in Mechanical Engineering from Washington University in St. Louis.
Tell Us Something Interesting:
I am leading implementation of the Medical Device Regulations at my company and I am very interested in collaborating on PLM and data management solutions bein pursued to manage a lot of data that must be pushed to external worldwide databases.
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